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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Nov. 22, 2017

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Parasite May Threaten Lives of Hundreds of Vietnam War Veterans A tropical parasite may be slowly killing hundreds of U.S. veterans of the Vietnam War. Early this year, the Department of Veterans Affairs commissioned a small pilot study to investigate the link between liver flukes ingested through raw or...

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Nature Walks Nurture Family Bonds

Posted today in Medical

THURSDAY, Nov. 23, 2017 -- Taking short walks together in nature can strengthen family ties, new research suggests. And family gatherings at Thanksgiving are the perfect settings for such strolls. "Past research shows that in nature individuals' attention is restored, but we wanted to know what does that mean for family relationships? In our theoretical model, we made the case that when an individual's attention...

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Arthritis Didn't Afflict Famed Clone Sheep, Experts Say

Posted today in Medical

THURSDAY, Nov. 23, 2017 -- Dolly the sheep did not have early onset osteoarthritis after all, according to new research. Experts at the University of Glasgow and the University of Nottingham in the United Kingdom said their findings dispel original concerns about the nature and extent of osteoarthritis in Dolly, the first animal to be cloned from adult cells. In 2003, reports suggested that Dolly was suffering...

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Thanksgiving Overeating Could Spell Kidney Problems

Posted today in Medical

THURSDAY, Nov. 23, 2017 -- Holiday overeating can harm your kidneys, a kidney expert warns. "The body absorbs nutrients from the gut and then the liver metabolizes them. Whatever is left that can't be used by the body is excreted by the kidneys," Dr. Sreedhar Mandayam, a specialist in nephrology at Baylor College of Medicine, said in a college news release. "The more you eat, the more you deliver to your kidneys...

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How to Safely Navigate Diabetes and Thanksgiving

Posted today in Medical

THURSDAY, Nov. 23, 2017 -- People with diabetes can have a healthy and safe Thanksgiving dinner if they follow certain guidelines, a diabetes expert says. The keys are pre-planning and moderation, according to Dr. Vanessa Arguello. She is a health sciences clinical instructor in the division of endocrinology, diabetes and metabolism at the UCLA School of Medicine in Los Angeles. People with diabetes still need to...

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FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection

Posted 2 days ago in New Drug Approvals

November 21, 2017 -- The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1...

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FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma

Posted 7 days ago in New Drug Approvals

November 16, 2017 -- The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back. “This is the first a...

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FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors

Posted 7 days ago in New Drug Approvals

November 16, 2017 -- The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. “Reducing the frequency or preventing bleeding episodes is an important part of disease management for patients with hemophilia. Today’s app...

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FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma

Posted 8 days ago in New Drug Approvals

South San Francisco, CA -- November 16, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The approval is based on...

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Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

Posted 8 days ago in New Drug Approvals

DUBLIN, Nov. 15, 2017 /PRNewswire/ -- Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug Administration of Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and pediatric...

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FDA Grants Marketing Authorization of the First Device for Use in Helping to Reduce the Symptoms of Opioid Withdrawal

Posted 8 days ago in Pharma Industry News

November 15, 2017 -- Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs ...

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Theravance Biopharma and Mylan Submit NDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

Posted 10 days ago in New Drug Applications

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Nov. 13, 2017 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ, TASE: MYL) ("Mylan") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized...

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Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

Posted 2 weeks ago in New Drug Applications

MARLBOROUGH, Mass.--(BUSINESS WIRE) November 10, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents...

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FDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer

Posted 3 weeks ago in Pharma Industry News

November 1, 2017 -- As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of t...

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Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder

Posted 3 weeks ago in New Drug Applications

Princeton, N.J.—November 1, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disor...

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Monthly News Roundup - October 2017

Posted 3 weeks ago in Pharma Industry News

Yescarta CAR T-Cell Therapy Approved for Lymphoma Novel chimeric antigen receptor T cell (CAR T) therapy allows patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration (FDA) has cleared Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel), the first CAR T-cell treatment for adults with large B-cell lymphoma after failing at least two o...

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GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling NDA Submission to U.S. FDA for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome

Posted 3 weeks ago in New Drug Applications

LONDON and CARLSBAD, Calif., Oct. 30, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ("GW" or "the Company"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced it has completed the rolling submission of a New Drug Application (NDA)...

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AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

Posted 4 weeks ago in New Drug Applications

NORTH CHICAGO, Ill., Oct. 27, 2017 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated...

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Monthly News Roundup - September 2017

Posted 7 weeks ago in Pharma Industry News

FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex) in patients with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy; or as monotherapy for patients who previously rec...

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FDA Improves Access to Reports of Adverse Drug Reactions

Posted 8 weeks ago in Pharma Industry News

September 28, 2017 -- The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. "Tools like the FDA Adverse Event Reporting System are ...

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Acorda Discontinues Tozadenant Development Program

Posted 3 days ago in Clinical Trials

ARDSLEY, N.Y.--(BUSINESS WIRE)--November 20, 2017 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the ...

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Three-year Follow-up Phase 3 Data Provide Additional Information on Efficacy, Durability and Safety of Investigational Luxturna (voretigene neparvovec) in Patients with Biallelic RPE65-mediated Inherited Retinal Disease

Posted 13 days ago in Clinical Trials

PHILADELPHIA, Nov. 10, 2017 (GLOBE NEWSWIRE) -- Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, today announced new three-year follow-up data from the continuing Phase 3 trial of Luxturna™ (voretigene neparvovec), an investigational, potential one-time gene therapy for the treatment of patients with vision loss due to confirmed b...

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Sage Therapeutics Announces Brexanolone Achieves Primary Endpoints in Both Phase 3 Clinical Trials in Postpartum Depression

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 9, 2017-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone (USAN; formerly SAGE-547); Study 202B in severe postpartum depression...

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Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer

Posted 2 weeks ago in Clinical Trials

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)--Nov. 8, 2017-- Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”), today announced dosing of the first patient in EV-103, a phase 1b clinical trial evaluating the safety and tolerability of enfortumab vedotin in combination with pembrolizumab or atezolizumab, two types of immune checkpoint inh...

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New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer's Disease

Posted 2 weeks ago in Clinical Trials

TOKYO, Nov 6, 2017 - (ACN Newswire) - Eisai Co., Ltd. announced today that Biogen Inc. (Nasdaq: BIIB) presented new data from the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, an investigational treatment for Alzheimer's disease at the 10th Clinical Trials on Alzheimer's Disease (CTAD) meeting, Boston, Massachusetts, United States, from November 1 to 4. As of October 23, 2017, Eisai and...

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